Senior Manager, Quality - NPI
Listed on 2026-01-03
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Engineering
Quality Engineering -
Quality Assurance - QA/QC
Quality Engineering
Stryker is seeking a Senior Manager, Quality – NPI to lead a high-performing team at the forefront of innovation in medical device manufacturing. While this role offers remote flexibility, we strongly prefer candidates located near one of our key office hubs:
Salt Lake City, UT or Irvine, CA.
As Senior Manager, Quality – NPI
, you’ll lead a high-performing team driving product transfers that meet the highest standards of quality, safety, and compliance. In this hands‑on leadership role, you’ll play a pivotal part in our NPI Quality team—mentoring engineers, guiding cross‑functional collaboration, and ensuring every product transfer meets the highest standards of quality, safety, and regulatory compliance. Your work will directly shape the future of life‑changing medical technologies
- Drive execution of NPI strategy to develop scalable, high‑yield processes that meet launch timelines and quality targets.
- Optimize inspection strategies through technology, automation, and supplier certification to reduce inspection cost per unit.
- Coach and develop a team of quality engineers to ensure product transfers meet or exceed established performance metrics.
- Ensure compliance by implementing robust production and process controls throughout the manufacturing lifecycle.
- Collaborate globally with QA leaders to harmonize best practices and share lessons learned across regions.
- Lead supplier onboarding by validating process capability and implementing pFMEA, PPAP, and certification requirements.
- Drive continuous improvement in metrology, process validation, and inspection methods to enhance efficiency and accuracy.
- Monitor and improve product quality indicators such as supplier DPM, right‑first‑time rates, and manufacturing complaints per million units.
- Bachelor’s degree in Engineering or Science discipline (or equivalent).
- Minimum 10 years of experience in a regulated manufacturing environment (medical device, pharmaceutical, biomedical, or automotive).
- Minimum 6 years of experience leading and developing high‑performing teams.
- Expert knowledge of regulatory requirements and standards, including FDA inspections/audits.
- Proficiency in quality tools such as SPC, FMEA, Root Cause Analysis, and Six Sigma methodologies.
- Up to 30% domestic and international travel.
- MBA or advanced degree in Business Management.
- Experience across multiple sites or roles within quality organizations.
- Familiarity with metrology and interpretation of complex engineering drawings.
$129,600 - $286,500 salary plus bonus eligible + benefits. Individual pay is based on skills, experience, and other relevant factors.
Posted: 1/1/2026.
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